Pubo-vaginal incontinence device

ABSTRACT

A pubo-vaginal device for females afflicted with urinary incontinence. The device consists of a silicone rubber unit provided with an element adapted to be removably inserted in the vagina and an exterior member integral with the element and designed to lie against the pubic region of the wearer. A supporting belt having straps secured to the member engaging the pubic area maintains the unit in a location so that the element is normally held in a position causing the same to exert an upward thrust against the anterior wall of the vagina of sufficient magnitude to block flow of urine from the bladder through the urethra to the urethral opening.

United States Patent m1 ,5

[72] Inventor Henry N. Habib 2,649,086 8/1953 Sluijter 128/1 440 E. 74th Terrace, Kansas City, Mo. 3,080,865 3/1963 Vincent 128/98 64131 3,347,238 10/1967 Gresham 128/295 [21] Appl. No. 721,959 3,372,695 3/1968 Beliveau et a1. 128/IX [22] Filed Apr.-17, 1968 3,419,008 12/1968 Plishner 128/1X [45 1 Patented 1971 Primary ExaminerCharles F. Rosenbaum Attorney-Schmidt, Johnson, Hovey, Williams and Chase [54] g-QNTINENCE DEVICE ABSTRACT: A pubo-vaginal device for females afflicted with 9 8 8 urinary incontinence. The device consists of a silicone rubber 'U.S.

unit provided with an element adapted to be removably in- 123/346, 123/295, 128/98 serted in the vagina and an exterior member integral with the Int- Cl. element and designed to again t the pubi region of th [50] Field of Search 128/1, 160, w rer. A supporting belt having straps secured to the 98, 295, 346 member engaging the pubic area maintains the unit in a location so that the element is normally held in a position causing [56] References cued the same to exert an upward thrust against the anterior wall of UNITED STATES PATENTS the vagina of sufficient magnitude to block flow of urine from 2,483,079 9/1949 Williams 128/295 the bladder through the urethra to the urethral opening.

PUBO-VAGINAL INCONTINENCE DEVICE This invention relates to a pubo-vaginal device for controlling urinary incontinence in women as well as young girls and has particular application in those instances where corrective surgery is not practical, must be postponed, simply will not be consented to by the patient, or involves the problem of juvenile enuresis.

Urinary incontinence in the female is a particularly vexatious and troublesome problem because persons so afflicted have no ability to retain any significant volume of urine in the bladder especially under stress conditions which involve nothing morecomplicated than standing and performing normal'daily tasks that require moving about man upright stance. Even women who canwalk about without uncontrolled voiding of the bladder but are-inclined to incontinence will often involuntarily release urine from the urethral opening when stress is placed on the area of the bladder as for example by coughing or sneezing. Stress incontinence is characterized by a spurt of urine'from the urethra when any type of pressure is placed on the bladder.

' Although surgery is the preferred method of correcting female urinary incontinence this is often not the practical solution, especially where previous surgery-has failed, the patient is markedly obese and usually. severely hypertensive thus making surgical correction undesirable, and in small girls who suffer from nervous disorders or paralysis of the muscles which control the normal functioning of'the bladder and urethra. In these instances, it has heretofore been necessary for patients sufferin'gfroin urinary incontinence towe'ar pads in the nature of diapers or employ a catheter connected to a bag suspended from the wearers leg or a belt around her waist. Pads are not a satisfactory solution overall because they rapidly become moist, can cause infection and inflammation of the skin'that is exposed to the urine", and also rapidly cause an undesirable uriniferous odor. Catheters are not recommended because they also cause infection,- can result in the formation of stones in the urinary system, product tissue irritation, can-relatively easily plug up and are not compatible with normal activity. In addition the patient inu'st return frequently to the hospital for removal and replacement of the catheter in an effort to avoid a serious infection which .would rapidly become serious if left untreated.

Operations for the most part consist of a retropubic procedure in which the urethra and 'vesic'o-u'rethra angleand anterior bladder wall are attached tothe 'periosteum of the pubis and the fascia of the rectus with; interrupted catgut sutures. postoperative effect of this surgical procedure is elongation of the urethra and angulation of the vesical neck.

There is ahead though for means to control urinary incontinence in women and young girls without resort to surgery for reasons noted above aswell as during the time period which may elapse before an operation can be'perforrned. This time factor is often dictated by the convenience of the patient, availability of hospital beds and the schedule of the surgeon even though it is contemplated thatan incontinent condition ultimately be repaired by surgery.

. It is therefore the primary object of the present invention to provide a pubo-vaginal device for controlling various types of urinary incontinence infemales and which in various embodisuspended from a body encircling belt and strap assembly in disposition such that the vaginal element is disposed to produce an upward thrust on the anterior wall of the vagina in a direction and with sufficient force to block flow of urine from the bladder to the urethral opening while the device is in place.

It is another important object of the invention to provide a pubovaginal device which may be constructed of a highly stable, resilient, nonallergenic and nonirritating synthetic resin material such as silicone rubber which has been fully approved for use in medical applications and is known to be noninjurious to tissue even if used thereagainst for extended periods of time.

Another important object of the invention is to provide an incontinence control device which may be easily placed in position by the patient herself without assistance from a doctor'after initial fitting thereof and which may be just as easily removed for voiding of the bladder, or when retiring for the evening.

An equally important object of the invention is to provide a pubo-vaginal incontinence device which is adapted to be constructed of a resilient nonirritating, nonallergenic synthetic A still further important aim of the invention is to provide a.

device for controlling female urinary incontinence which may be constructed in various forms. depending upon the physiological condition of the particular patient causing the incontinence problem and which is operable to ,either compress the urethra so as to block flow of urine therethrough, to close the vesical-urethra junction and'thereby prevent release of urine from the bladder, or both as dictated by the particular circumstances unique to each individual patient.

A further important object of the invention is to provide a device as described which is completely effective to prevent involuntary release of urine from'the persons bladder during wearing of the device and which may be manufactured and distributed at a reasonable cost thus making the assembly available to all patients afflicted with the problem without significant regard to their financial status.

In the drawing:

FIG. 1 is a perspective view of a pubo-vaginal device constructed in. accordance with the preferred principles of the present invention and showing the resilient unit having an element adapted to be received in the .wearers vagina and an external member engageable with the pubic region to retain the element in blocking relationship to the flow of urine from the bladder to the urethral opening, and with preferred supporting belt and strap structure being illustrated for retaining the resilient unit in an operative position;

FIG. 2 is an essentially schematicrepresentation of a sagittal section of an incontinent woman wearing the resilient unit of the pubo-vaginal device and showing the relationship of the vaginal element to the external pubic member portion thereof ments thereof is effective to control such incontinence notwithstanding differences in their age and physical condition. Thus, the device may be used by patients awaiting surgery as well as those who cannot tolerate surgery for medical or psychological reasons. In addition the device may serve as a means for controlling juvenile enuresis and as a test for patients whose urinary incontinence is mechanical and who are definite candidates for surgery but require detailed medical examination and observation before it can be definitely determined that the person is a candidate forcorrective surgery.

It is another very important object of the invention to provide a resilient ,pubo-vaginal unit for a device useful in the treatment of urinary incontinence and having an element adapted to be inserted in the patients vagina and supported therein by an external member connected thereto that is to prevent flow of urine from the bladder through the urethra to the urethral opening;

FIG. 3 is a side elevational view of a modified pubo-vaginal unit constructed in accordance with the present invention with the supporting belt and strap structure therefor not being shown for clarity of illustration; I

FIG. 4 is a schematic diagram similar to FIG. 2 and showing a sagittal section ofa incontinent woman wearing the unit of FIG. 3;

FIG. 5 is a perspective view of a pubo-vaginal unit generally similar to the one shown in FIG. I, but in this case employing different means for selective securing of the belt and strap support structure thereto; and FIG. 6 is a side elevational viewof a pubo-vaginal resilient unit of the type especially usable with young girls suffering from enuresis or nervous disorders that result in urinary incontinence.

A pubo-vaginal device made in accordance with the preferred embodiment of the invention is illustrated in FIGS. 1 and 2 and broadly designated by the numeral 10. The principal components of device comprise a resilient unit 12 and supporting structure 14 therefor adapted to encircle the body of the wearer.

The unit 12 is generally U-shaped and has an elongated, smooth surfaced, preferably transversely circular element 16 integral with an external member 18 of generally L-shaped configuration and thereby having an elongated primary leg 18 adapted to lie against the pubic region in form engagement therewith, along with an intermediate secondary leg 18b which normally spans the pubic symphysis. The member 18 is also preferably smooth surfaced and of a shape to overlie the pubic region directly adjacent to the pubic bone thereunder.

Structure 14 for supporting the resilient unit 12 comprises an elastic belt 20 adapted to encircle the wearer at the top of the hips. The rear strap assembly 22 is of elastic material which extends through an opening 24 in secondary leg 18b of member 18 at the zone of juncture thereof with element 16. As a consequence, strap assembly 22 has a pair of separate sections 22a and 22b which are attached to the rear part of belt 20 by fasteners 25.

The front strap assembly 26 extends through an opening 28 in the normally uppermost end of leg 18a of member 18 and has a pair of spaced sections 26a and 26b slidably joined to the front part of belt 20 for sliding movement therealong. The ends of sections 26a and 26b are looped over belt 20 and adjustably received in retainer buckles 26c. Snap fasteners 26d interposed in sections 26a and 26b below buckles 260 permit selective disconnection of the lower parts of sections 26a and 26b from belt 20.

It is preferred that the unit 12 be constructed of a resilient synthetic resin material of the nonirritating, nonallergenic type which has been approved for use in medical applications where it is in direct contact with tissue and especially moist, easily irritated tissue of the type found within the vaginal cavity. An especially useful synthetic resin for this purpose has been found to be a product sold by Dow Corning Corporation, East Lansing, Michigan under the trade designation of Silastic" type No. 802 which is produced from S-2000 grade Silastic" dough. This product may be purchased in the form of a block one-half inch thick and measuring 3%inches by 4 inches. A block of this size is ideal for preparing unit 12, or the synthetic resin material may be molded in roughly the correct, generally U-shaped configuration and then carved to size. In both instances, the preferred material readily lends itself to being carved with a surgical knife to the desired final shape and size.

The resilient unit 12 is initially constructed so that there is approximately a 60 angle between element 16 and primary leg 18a of member 18. However, this angle increases upon insertion of element 18 into the vaginal cavity which is an important feature of device 10 so that proper pressure is exerted on the anterior vaginal wall as will be hereinafter explained.

In preparing the pubo-vaginal device 10 for an individual patient, the physician first makes a digital examination to determine the relationship of the base of the patients bladder relative to the entrance to the vaginal cavity. After locating this point and determining the distance thereof from the open ing of the vagina, the physician then shapes the element 16 so as to present a smooth outer surface preferably somewhat circular in cross section and of a length so that the outer extremity of the element is adapted to engage the anterior wall of the vagina adjacent the junction of the patient's bladder with the urethra. The relationship of element 16 in preferred form to the bladder and urethra are illustrated in the sagittal section of FIG. 2.

In the use of device 10, the belt 20 is slipped into position and element 16 inserted into the vagina with L-shaped member 18 positioned in firm engagement with the pubic area directly overlying the pubic bone. The strap sections 260 and 2617 are drawn downwardly through the buckles 26c until the straps force the unit 12 into firm engagement with the pubic region as best shown in FIG. 2. The straps 26 are also shifted along the front section of belt 20 until a comfortable fit is obtained. As a consequence, the element 16 is forced into engagement with the anterior wall surface of the wearer's vagina and member 18 is pressed into firm engagement with the pubic region in disposition where supporttherefor is provided by the pubic bone. The element 16 is thus held in a position causing the same to exert an upward thrust against the ante or wall of the vagina of sufficient magnitude to block flow of urine from the bladder through the urethra to the urethral opening. This mechanical blocking action is believed to occur because of (I) obstruction of the urethra by pressure thereagainst especially at the part thereof which merges with the opening into the bladder, (2) vesical-urethra kinking with the outer extremity of element 16 producing a forward and upward thrust against the base of the bladder, and (3) simple support for the bladder which is especially useful when it approaches being filled to capacity.

It is important that the supporting structure 14 hold the L- shaped member 18 in a fixed position against the pubic region of the wearer of device 10 so as to prevent movement of element 16 out of critical position thereof blocking flow of urine from the bladder through the urethra. This blockage is enhanced not only because of the disposition of the element 16 as shown in FIG. 2, but also by virtue of the fact that even though element 16 integral with leg member 18 is held relatively immobile, the element 16 is able to move slightly as necessary to compensate for changes in the angle of the vagina during normal movements of the wearer in performing functions such as bending over, sitting down or lifting objects.

The connection of rear strap sections 260 and 26b to secondary leg 18d of unit 12 adjacent the zone of merger thereof with element 16 is especially important because the tension on the unit provided by the elastic straps causes the element 16 to be slightly rotated counterclockwise viewing FIG. 2 upon insertion of the element in the vaginal cavity. As a result, the outer end of element 16 is moved toward the anterior wall of the vagina a sufiicient extent to produce the necessary upward and forward forces on the urethra and junction thereof with the bladder to effectively block flow of urine through the urethral canal.

After fitting of the device 10 by the physician, he makes certain that it is effective by having the patient cough or simulate a sneeze to place stress on the muscles surrounding the bladder and urethra. If the device is of proper size and posi' tioned in a correct location, no urinary leakage will occur.

The unit 12 may be easily shifted to a position for voiding o the bladder by simply disconnecting fasteners 26b and moving the unit 12 downwardly until the element 16 is completely out of the vagina. The resilient straps 22a and 22b permit such downward movement of the unit 12 while at the same time providing the necessary bias on member 18 when the unit 12 is in an operative disposition.

The modified pubo-vaginal device illustrated in FIGS. 3 and 4 utilizes supporting structure similar to structure 14, but em ploys a resilient U-shaped unit 112 of somewhat different shape than unit 12. The L-shaped member 118 of unit 112 is similar to that found in unit 12, but the J-shaped element 11 is located so that the opening to the loop thereof faces the re r side of the juncture between primary leg 118a and secondary leg 118b of member 118. Unit 112 is also preferably constructed of the silicone rubber material described above and in this case, the outer part of element 116 is shaped so as to pro vide pressure against the anterior wall of the vagina in compressing relationship to the urethra below the junction thereof with the bladder. As a consequence, the urethra is blocked off so that urine cannot fiow therethrough but an upward compressive force is not placed against the junction of the bladder with the urethra as is the case with element 16 of unit 12. Unit 112 has particular application where the patient has a spastic bladder and the compression of the urethra is adequate to prevent involuntary flow of urine from the urethral opening.

The resilient unit 212 shown in FIG. is of a shape similar to that of unit 12 except that flat segments 218a and 218d are provided on the primary leg 218a and secondary leg 21% of member 218. These flat segments serve as mounting points for the male sections 230 of conventional snap fasteners, the

female sections of which are mounted on the straps of the supporting structure therefor similar to structure 14. The use of snap fasteners has a special utility ;where essentially nonresilient straps are used for suspension of the unit212 from a belt, to permit selective disengagement iofthe straps from the resilient unit 212 for removal thereof.

The resilient unit 312 of FIG. 6 comprises another embodiment of the invention and which has a special utility in the case of urinary incontinence in young girls caused by nervous disorders or paralysis. In addition, device 312 has utility in alleviating the problems associated with juvenile enuresis.

In the case of unit 312, the element 316 is at a much more acute angle relative tothe L-shaped member 318 and is of much smaller size to be accommodated in the vaginal cavity of the small child. Preferred means for supporting unit 312 is again an assembly similar to supportingstructure 14. Note should particularly be taken of the relatively' short secondary leg 318b connected to the primary leg 318a of member 318 to accommodate the relatively small pubic'area of the small girl suffering from any type of urinary incontinence. I

' Various grades of the silicone rubber material may be used depending upon the pressure needed to blockthe urethra and the proper hardness may be employed for a particular application. For example, where a small and thinvaginal element 16 is required as for example in the case of element 316 of unit 312, a somewhat less resilient silicone rubber composition may be used with relatively firm Silastic type No. 803 being preferred. In all instances though, the material should lend itself to sizing for each patient based on vaginal examination to determine the most effective place for application of pressure to the urethra or bladder or both. 7 I

I claim: I

1. A pubo-vaginal device for controlling female urinary incontinence comprising:

an elongated resilient element adapted to be inserted in the vagina of the incontinent female and removable therefrom at will; e member connected to said element and cooperating therewith to present a generally U-shaped monolithic unit with the element disposed at an' acute angle relativeto the member, and adapted to lie against the pubic region of the wearer of the device when the element is fully inserted in the vagina, said element and the member being resiliently interconnected and located in relative dispositions prior to insertion of the element in the vagina of the wearer causing the angle between the element and said member to be less than the angle between the anterior wall of the vagina and said pubic re'gionof said wearer,

said member being of a length that upon full insertion thereof in thevagina, the member isfoperable to hold the element in a position causing the same to exert an upward thrust against the anterior wall'of the. vagina of sufficient magnitude to block flow of urine from the bladder through the urethra to the urethral opening; and means joined to said member for normally holding the latter firmly against the pubic region, to retain the element in said position thereof. 2. A device as set forth in claim 1, wherein said element is prior to insertion of the element in the yagina ofthe wearer.

outermost extremity of the element for connecting the latter to said primary leg of the member.

4. A device as set forth in claim 3, wherein said secondary leg is of a length substantially equal to the length of the pubic symphysis of the wearer of said device.

5. A device as set forth in claim 1, wherein said means for holding the member comprises a belt for encircling the body above the member and a series of straps suspended from the belt and joined to said member to hold the latter against said pubic region. i

6. A device as set forth in claim 5, wherein is provided from straps secured to the normally uppermost end portion of the member and to the front section of the belt, and rear straps secured to the normally lowermost portion of the member and to the rear section of the belt.

7. A device as set forth in claim 6. wherein said rear straps are longitudinally elasticto facilitate removal of the element from the vagina for voiding of urine without the necessity of removing the device from the wearer's body. I

8. A device as set forth in claim 6, wherein said member is provided with holes therein for receiving the front and rear straps respectively.

9. A pubo-vaginal device for controlling female urinary incontinence comprising:

an elongated resilient element adapted to be inserted in the vagina of the incontinent female and removable therefrom at will; a member connected to said'element in supporting relationship thereto and adapted to be against the pubic region of the wearer of the device whenithe element is fully inserted in the vagina, said element and the member being of pliable synthetic resin material and the element being of a length that upon insertion thereof in the vagina and the member is in engagement with said pubic region, the terminal end portion of the element is located to press against the anterior wall of the vagina adjacent the junction of the urethra and the bladder to push the base portion of the bladder upwardly and forwardly toward the pubic bone in conjunction with compression of the urethra to block flow of urine from the bladder through the urethra to the urethral opening; and

means joined to said member for normally holding the latter against the pubic region to retain the element in the urethra blocking position thereof.

10. A device as set forth in claim 9, wherein said material is silicone rubber.

positioned at an angle of about 60 relative to the member 3. A device-as set forth in claim 1, wherein said member is of generally L-shaped configuration'and has an elongated primary leg adapted to lie against the pubic region and a secondary leg shorter thansaid primary leg joined to the normally 11. A pubo-vaginal device for controlling female urinary incontinence comprising:

an elongated resilient J-shaped element adapted to be inserted in the vagina of the incontinent female and removable therefrom at will;

a member connected to said element in supporting relationship thereto and adapted to lie against the pubic region of the wearer of the device when the element is fully inserted in the vagina, said member being operable to hold V the element in a position causing the same to exert an upward thrust against the anterior wall of the vagina of suffrcient magnitude to block flow of urine from the bladder 

1. A pubo-vaginal device for controlling female urinary incontinence comprising: an elongated resilient element adapted to be inserted in the vagina of the incontinent female and removable therefrom at will; a member connected to said element and cooperating therewith to present a generally U-shaped monolithic unit with the element disposed at an acute angle relative to the member, and adapted to lie against the pubic region of the wearer of the device when the element is fully inserted in the vagina, said element and the member being resiliently interconnected and located in relative dispositions prior to insertion of the element in the vagina of the wearer causing the angle between the element and said member to be less than the angle between the anterior wall of the vagina and said pubic region of said wearer, said member being of a length that upon full insertion thereof in the vagina, the member is operable to hold the element in a position causing the same to exert an upward thrust against the anterior wall of the vagina of sufficient magnitude to block flow of urine from the bladder through the urethra to the urethral opening; and means joined to said member for normally holding the latter firmly against the pubic region to retain the element in said position thereof.
 2. A device as set forth in claim 1, wherein said element is positioned at an angle of about 60* relative to the member prior to insertion of the element in the vagina of the wearer.
 3. A device as set forth in claim 1, wherein said member is of generally L-shaped configuration and has an elongated primary leg adapted to lie against the pubic region and a secondary leg shorter than said primary leg joined to the normally outermost extremity of the element for connecting the latter to said primary leg of the member.
 4. A device as set forth in claim 3, wherein said secondary leg is of a length substantially equal to the length of the pubic symphysis of the wearer of said device.
 5. A device as set forth in claim 1, wherein said means for holding the member comprises a belt for encircling the body above the member and a series of straps suspended from the belt and joined to said member to hold the latter against said pubic region.
 6. A device as set forth in claim 5, wherein is provided front straps secured to the normally uppermost end portion of the member and to the front section of the belt, and rear straps secured to the normally lowermost portion of the member and to the rear section of the belt.
 7. A device as set forth in claim 6, wherein said rear straps are longitudinally elastic to facilitate removal of the element from the vagina for voiding of urine without the necessity of removing the device from the wearer''s body.
 8. A device as set forth in claim 6, wherein said member is provided with holes therein for receiving the front and rear straps respectively.
 9. A pubo-vaginal device for controlling female urinary incontinence comprising: an elongated resilient element adapted to be inserted in the vagina of the incontinent female and removable therefrom at will; a member connected to said element in supporting relationship thereto and adapted to be against the pubic region of the wearer of the device when the element is fully inserted in the vagina, said element and the member being of pliable synthetic resin Material and the element being of a length that upon insertion thereof in the vagina and the member is in engagement with said pubic region, the terminal end portion of the element is located to press against the anterior wall of the vagina adjacent the junction of the urethra and the bladder to push the base portion of the bladder upwardly and forwardly toward the pubic bone in conjunction with compression of the urethra to block flow of urine from the bladder through the urethra to the urethral opening; and means joined to said member for normally holding the latter against the pubic region to retain the element in the urethra blocking position thereof.
 10. A device as set forth in claim 9, wherein said material is silicone rubber.
 11. A pubo-vaginal device for controlling female urinary incontinence comprising: an elongated resilient J-shaped element adapted to be inserted in the vagina of the incontinent female and removable therefrom at will; a member connected to said element in supporting relationship thereto and adapted to lie against the pubic region of the wearer of the device when the element is fully inserted in the vagina, said member being operable to hold the element in a position causing the same to exert an upward thrust against the anterior wall of the vagina of sufficient magnitude to block flow of urine from the bladder through the urethra to the urethral opening; and means joined to said member for normally holding the latter firmly against the pubic region to retain the element in said position thereof.
 12. A device as set forth in claim 11, wherein said element is disposed with the opening to the loop thereof facing toward the member and constructed and arranged to the terminal end portion thereof to press against the anterior wall of the vagina at a location to compress the urethra and prevent flow of urine therethrough from the wearer''s bladder. 